Valproic Acid in Treating Patients With Kaposi's Sarcoma
- Conditions
- Sarcoma
- Registration Number
- NCT00075777
- Lead Sponsor
- AIDS Malignancy Consortium
- Brief Summary
RATIONALE: Valproic acid may help stop the growth of Kaposi's sarcoma cells by blocking the enzymes necessary for tumor cell growth.
PURPOSE: This clinical trial is studying valproic acid in treating patients with HIV-related Kaposi's sarcoma.
- Detailed Description
OBJECTIVES:
Primary
* Determine the safety of valproic acid in patients with Kaposi's sarcoma.
* Determine the effects of this drug on human herpes virus 8 (KSHV) gene expression using polymerase chain reaction and immunohistochemistry in these patients.
Secondary
* Determine the effects of this drug on HIV, KSHV, and Epstein-Barr virus viral loads in the plasma and peripheral blood mononuclear cells of these patients.
* Determine clinical response in patients treated with this drug.
OUTLINE: This is an open-label, pilot, multicenter study.
Patients receive oral valproic acid twice daily on days 1-28 followed by a drug taper over 2 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed monthly for 6 months.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 1 year.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Toxicity-related discontinuation rate 28 days Lytic induction rate 28 days Clinical response rate 28 days Accelerated KS progression rate 28 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (13)
Jonsson Comprehensive Cancer Center at UCLA
🇺🇸Los Angeles, California, United States
Veterans Affairs Medical Center - San Diego
🇺🇸San Diego, California, United States
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Georgia Cancer Center for Excellence at Grady Memorial Hospital
🇺🇸Atlanta, Georgia, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
🇺🇸Chicago, Illinois, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Siteman Cancer Center at Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Albert Einstein Cancer Center at Albert Einstein College of Medicine
🇺🇸Bronx, New York, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Scroll for more (3 remaining)Jonsson Comprehensive Cancer Center at UCLA🇺🇸Los Angeles, California, United States